预约演示

更新于：2025-02-25

Pamrevlumab

潘瑞鲁单抗

更新于：2025-02-25

概要

基本信息

药物类型

单克隆抗体

别名

Anti-CTGF antibody、Pamrevlumab (USAN/INN)、FG-3019

靶点

CTGF

作用机制

CTGF抑制剂(结缔组织生长因子抑制剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病

在研适应症

不能切除性胰腺癌

非在研适应症

新型冠状病毒感染胰岛素依赖型糖尿病22型糖尿病+ [7]

原研机构

FibroGen, Inc.

在研机构

FibroGen, Inc.Boehringer Ingelheim Pharma GmbH & Co., KG

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、罕见儿科疾病 (美国)、快速通道 (美国)

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结构/序列

Sequence Code 315648341L

来源: *****

Sequence Code 319372665H

来源: *****

关联

项与潘瑞鲁单抗相关的临床试验

CTR20221946

/ Terminated临床3期

Zephyrus II：一项评价 pamrevlumab 治疗特发性肺纤维化（IPF）有效性和安全性的 III 期、随机、双盲、安慰剂对照研究

本研究的总体目的是与安慰剂对比，在特发性肺纤维化患者中评价Pamrevlumab的有效性和安全性。

开始日期2022-11-11

申办/合作机构

珐博进（中国）医药技术开发有限公司

CTR20212110

/ Terminated临床3期

一项Pamrevlumab（FG-3019）或安慰剂联合全身性皮质类固醇治疗杜氏肌营养不良非卧床受试者的III 期、随机、双盲试验

评价Pamrevlumab与安慰剂相比，联合全身性皮质类固醇，每两周给药一次，治疗杜氏肌营养不良非卧床受试者（6岁至<12岁）的疗效和安全性。

开始日期2021-12-22

申办/合作机构

珐博进（中国）医药技术开发有限公司

[+2]

CTR20212108

/ Terminated临床3期

一项在卧床杜氏肌营养不良（DMD）受试者中研究Pamrevlumab（FG-3019）或安慰剂联合全身性皮质类固醇治疗的III 期、随机、双盲试验

评价pamrevlumab相比安慰剂联合全身性皮质类固醇治疗杜氏肌营养不良受试者（卧床、年龄12岁及以上）的有效性和安全性。

开始日期2021-12-09

申办/合作机构

珐博进（中国）医药技术开发有限公司

[+2]

100 项与潘瑞鲁单抗相关的临床结果

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100 项与潘瑞鲁单抗相关的转化医学

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100 项与潘瑞鲁单抗相关的专利（医药）

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项与潘瑞鲁单抗相关的文献（医药）

2024-09-01·CURRENT OPINION IN PULMONARY MEDICINE

Evidence from recent clinical trials in fibrotic interstitial lung diseases

Review

作者: Valenzuela, Claudia ; Cottin, Vincent

Purpose of review:

Idiopathic pulmonary fibrosis (IPF) is the prototype of fibrosing interstitial lung diseases. It is mirrored by progressive pulmonary fibrosis (PPF), an umbrella term which characterizes disease behavior of various fibrotic interstitial lung diseases with irreversible progression, accounting for loss of lung function, exercise intolerance and respiratory failure leading to early mortality. Pirfenidone and nintedanib halve the decline in lung function but do not halt disease progression.

Recent findings:

Since the publication in 2014 of pivotal pirfenidone and nintedanib studies, a number of clinical trials were conducted, many of them did not reach their primary endpoints. In IPF, promising phase 2 trials were followed by large phase 3 trials that did not confirm a favorable efficacy to tolerability favorable profile, including those with ziritaxestat, an autotaxin-1 inhibitor, zinpentraxin-alpha (human recombinant pentraxin-2), and the monoclonal antibody pamrevlumab targeting connective tissue growth factor. Nevertheless, newer compounds that hold promise are currently being evaluated in phase 3 or phase 2b randomized controlled trials, including: nerandomilast, a preferential phosphodiesterase 4B inhibitor; admilparant, a lysophosphatidic acid receptor antagonist; inhaled treprostinil, a prostacyclin agonist; and bexotegrast, a dual-selective inhibitor of αvβ6 and αvβ1 integrins. Nerandomilast, admilparant, inhaled treprostinil, and inhaled AP01 (pirfenidone), are currently studied in patients with PPF.

Summary:

Despite recent frustrating negative results, there is a growing portfolio of candidate drugs developed in both IPF and PPF.

2024-09-01·CURRENT OPINION IN PULMONARY MEDICINE

The future of clinical trials in idiopathic pulmonary fibrosis

Review

作者: Maher, Toby M. ; Spagnolo, Paolo

Purpose of review:

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a poor prognosis and limited therapeutic options. A multitude of promising compounds are currently being investigated; however, the design and conductance of late-phase clinical trials in IPF has proven particularly challenging.

Recent findings:

Despite promising phase 2 data, ziritaxestat, an autotaxin inhibitor, pentraxin-2, an endogenous protein that regulates wound healing and fibrosis, and pamrevlumab, a human monoclonal antibody against connective tissue growth factor, failed to show efficacy in phase 3 trials. Endpoint selection is critical for the design, execution, and success of clinical trials; recently, attention has been paid to the assessment of how patients feel, function, and survive with the aim of aligning scientific objectives and patient needs in IPF. External control arms are control patients that derive from historical randomized controlled trials, registries, or electronic health records. They are increasingly used to assess treatment efficacy in clinical trials owing to their potential to reduce study duration and cost and increase generalizability of findings.

Summary:

Advances in study design, end point selection and statistical analysis, and innovative strategies for more efficient enrolment of study participants have the potential to increase the likelihood of success of late-phase clinical trials in IPF.

2024-08-06·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Pamrevlumab for Idiopathic Pulmonary Fibrosis

Article

Importance:

Current treatments for idiopathic pulmonary fibrosis slow the rate of lung function decline, but may be associated with adverse events that affect medication adherence. In phase 2 trials, pamrevlumab (a fully human monoclonal antibody that binds to and inhibits connective tissue growth factor activity) attenuated the progression of idiopathic pulmonary fibrosis without substantial adverse events.

Objective:

To assess the efficacy and safety of pamrevlumab for patients with idiopathic pulmonary fibrosis.

Design, Setting, and Participants:

Phase 3 randomized clinical trial including 356 patients aged 40 to 85 years with idiopathic pulmonary fibrosis who were not receiving antifibrotic treatment with nintedanib or pirfenidone at enrollment. Patients were recruited from 117 sites in 9 countries between July 18, 2019, and July 29, 2022; the last follow-up encounter occurred on August 28, 2023.

Interventions:

Pamrevlumab (30 mg/kg administered intravenously every 3 weeks; n = 181) or placebo (n = 175) for 48 weeks.

Main Outcomes and Measures:

The primary outcome was absolute change in forced vital capacity (FVC) from baseline to week 48. There were 5 secondary outcomes (including time to disease progression, which was defined as a decline of ≥10% in predicted FVC or death). The exploratory outcomes included patient-reported symptoms. Adverse events were reported.

Results:

Among 356 patients (mean age, 70.5 years; 258 [72.5%] were men; 221 [62.1%] were White), 277 (77.8%) completed the trial. There was no significant between-group difference for absolute change in FVC from baseline to week 48 (least-squares mean, −260 mL [95% CI, −350 to −170 mL] in the pamrevlumab group vs −330 mL [95% CI, −430 to −230 mL] in the placebo group; mean between-group difference, 70 mL [95% CI, −60 to 190 mL], P = .29). There were no significant between-group differences in any of the secondary outcomes or in the patient-reported outcomes. In the pamrevlumab group, there were 160 patients (88.4%) with treatment-related adverse events and 51 patients (28.2%) with serious adverse events vs 151 (86.3%) and 60 (34.3%), respectively, in the placebo group. During the study, 23 patients died in each group (12.7% in the pamrevlumab group vs 13.1% in the placebo group).

Conclusions and Relevance:

Among patients with idiopathic pulmonary fibrosis treated with pamrevlumab or placebo, there was no statistically significant between-group difference for the primary outcome of absolute change in FVC from baseline to week 48.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03955146

137

项与潘瑞鲁单抗相关的新闻（医药）

2025-02-25

·药融圈

新药上市，又一家中国运营公司被收购

▲3月6-7日新药创新者峰会扫码报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。曾经的潜力股药融圈获悉：在2025年2月20日，跨国制药巨头阿斯利康与FibroGen/珐博进有限公司（美国纳斯达克股票代码：FGEN，简称“珐博进”）达成协议，将以约1.6亿美元收购珐博进中国。根据协议条款，珐博进将获得8500万美元的企业价值，以及交易交割时珐博进中国持有的约7500万美元现金，总计约1.6亿美元。该交易预计将于2025年中期完成交割，具体取决于包括中国监管审查在内的惯常交割条件等。完成交割后，阿斯利康将获得罗沙司他/Roxadustat在中国的所有权利。珐博进保留其在美国及未授权给安斯泰来的市场对罗沙司他的权利。交易完成后，珐博进公司将专注开发FG-3246（CD46靶向ADC候选药物，从Fortis Therapeutic授权引进）及其配套的PET成像剂FG-3180。在2023年5月，珐博进公司与Morgan Stanley Tactical Value签订了一项最高可达1.5亿美元的无稀释的定期贷款，期限为期三年，年利率为14%。后为拯救公司，珐博进彻底放弃Pamrevlumab开发，又裁掉了美国75%的员工。药融云数据，www.pharnexcloud.com；改名后为摩熵医药数据此前在2013年，阿斯利康以8.15亿美元的总交易额获得罗沙司他在美国、中国以及安斯泰来未授权地区的开发和商业化权益。据悉当前，新药罗沙司他主要业绩来自中国市场，本品于2018年底在中国获批上市，全球首次获批；目前在美国尚未获批： 2021年：国内销售13亿元人民币。 2022年：国内销售1.97亿美元（约近14亿人民币）。 2023年：国内销售2.84亿美元（约20.6亿人民币），同比增长40%。此前业内预计罗沙司他2024年的销售额预计将达到25-30亿元人民币。罗沙司他是全球首个开发的小分子低氧诱导因子脯氨酰羟化酶抑制剂（HIF-PHI）类药物，用于治疗慢性肾病相关疾病引起的贫血。2024年7月，石药集团的罗沙司他胶囊仿制药已在国内获批上市。目前还有多款罗沙司他胶囊仿制药的上市申请已获得受理。新药纠纷本靶点新药曾经还有一段插曲：2024年4月16日，杭州安道药业有限公司和Kind制药有限责任公司（“安道药业”），和其首席执行官刘栋博士和首席科学官邓绍江博士宣布他们解决了与FibroGen，Inc. (珐博进)关于安道药业的缺氧诱导因子脯氨酸羟基化酶抑制剂（HIF-PHI）最近的技术争端。各方已经同意撤回彼此之间关于这项HIF-PHI技术的所有待解决的法律诉讼，而无需任何一方支付费用。参考： NMPA/CDE；摩熵医药数据pharma.bcpmdata.com（原药融云数据）； FDA/EMA/PMDA； FG-3246 is comprised of an anti-CD46 antibody, YS-5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload； https://www.astrazeneca.com.cn/zh/media/press-releases/2025/02-20-01.html； https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-sale-fibrogen-china-astrazeneca-approximately；等等。此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐。更多药企信息交流可后台留下名片。日程以现场为准

并购抗体药物偶联物上市批准引进/卖出

2025-02-22

·蒲公英Ouryao

豪掷11亿！一场“诺奖级”药物与市场博弈的豪赌

转自：蒲公英Ouryao 综合：无忧 2月20日，阿斯利康宣布以约1.6亿美元收购珐博进中国业务，全权获得抗贫血药物罗沙司他在中国的所有商业化权益。 2月20日，全球制药巨头阿斯利康宣布以约1.6亿美元收购珐博进中国业务，全权获得抗贫血药物罗沙司他在中国的所有商业化权益。交易预计于2025年中期完成，目前正等待中国监管部门批准。交割后，阿斯利康全面接管罗沙司他在中国的销售与开发，珐博进保留美国及其他未授权市场的权益。罗沙司他：从“诺奖光环”到中国市场的崛起罗沙司他是全球首个基于2019年诺贝尔生理学或医学奖“细胞氧感知机制”研发的HIF-PHI类药物，用于治疗慢性肾病（CKD）贫血，填补了30年口服创新药空白。 2023年销售额达2.84亿美元（约20.6亿元人民币），同比增长40%，稳居中国肾病贫血市场首位。 2019年纳入医保后，年销售额从2020年的5.91亿元跃升至2023年的22.61亿元。中国是罗沙司他全球首发地，打破了跨国药企“欧美先批、中国进口”的惯例，成为首个在中国率先上市的外资全球新药。交易逻辑：阿斯利康的野心与珐博进的困境阿斯利康的布局：罗沙司他与中国市场深度绑定，可强化阿斯利康在非肿瘤领域的竞争力，尤其是百亿级肾病贫血市场。与现有肿瘤药物（如度伐利尤单抗）形成组合疗法潜力，拓展化疗相关性贫血（CIA）等新适应症。珐博进的断臂求生：主力药物潘瑞鲁单抗（pamrevlumab）多项Ⅲ期临床试验失败，导致2023-2024年裁员超75%，出售中国业务可延长现金储备至2027年。资金将用于推进FG-3246（CD46ADC）等肿瘤管线，放弃非核心资产。值得注意的是，2024年6月，罗沙司他化合物专利失效；晶型专利因被中国法院宣告无效，仿制药上市时间大幅提前。仿制药方面，石药集团首仿药已获批，正大天晴、齐鲁制药等20余家药企仿制药排队上市，形成“围剿”之势。 Biotech寒冬下的生存法则珐博进的案例折射出Biotech在资本寒冬中的困境：核心管线失败后，出售优质资产成为续命关键。阿斯利康通过收购强化非肿瘤业务，但需应对中国区高层动荡（如前总裁王磊被查）及税务纠纷等合规风险。此次收购不仅是两家企业的战略调整，更揭示了医药行业的深层逻辑： “现金牛”生命周期管理需兼顾专利防御、市场教育与资本运作； Biotech的生存路径从“烧钱研发”转向“断臂求生”，合作与出售或成新常态。对于行业而言，合规与创新仍是穿越周期的核心命题；对于患者，这场博弈或将带来更可及的用药选择。参考：新京报、财联社、美通社等报道。推荐阅读：蒲公英Ouryao视频号投稿、广告、商务合作： Qinrenlvcha

并购临床3期专利到期

2024-11-12

·GlobeNewswire-Health Care

FibroGen Reports Third Quarter 2024 Financial Results

Topline results from Phase 2 portion of the investigator-sponsored study of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) are expected in 1H 2025Initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC anticipated in 1Q 2025Third quarter net revenue growth of 15% year over year, driven by strong performance of roxadustat in China, with year over year volume growth of 34% Reiterate full year net product revenue guidance of $135 million to $150 million, representing full year total roxadustat net sales in China1 between $330 million to $350 million Meaningful progress on U.S. cost reduction plan Expected to be substantially complete by year-end 2024 Cash, cash equivalents and accounts receivable balance of $160.0 million SAN FRANCISCO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2024 and provided an update on the company’s recent developments. “This past quarter we transformed into a lean and more focused organization, resulting in significant cost savings that will extend into the future. Moreover, roxadustat continued its impressive performance, generating $96.6 million in net sales in China during the quarter,” said Thane Wettig, Chief Executive Officer, FibroGen. “Having implemented our cost reduction plan, we are well positioned to advance FG-3246, with topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide at the University of California San Francisco (UCSF) on track for the first half of 2025, and the anticipated start of our Phase 2 monotherapy trial in the first quarter of 2025. We continue to be optimistic about our future prospects.” Recent Developments and Key Events of Third Quarter 2024: Meaningful progress on U.S. cost reduction plan. Expected to be substantially complete by year-end 2024 Reported topline results from the pamrevlumab arm of PanCAN Precision Promise Phase 2/3 adaptive platform trial for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), in which the trial did not meet the primary endpoint.Reported topline results from the LAPIS Phase 3 study of pamrevlumab in patients with locally advanced, unresectable pancreatic cancer (LAPC), in which the trial did not meet the primary endpoint. Upcoming Milestones: Roxadustat Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in early 2025. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca. FG-3246 and FG-3180 (PET Imaging Agent) Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 1H 2025.Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025. This trial will include a sub-study of FG-3180 to enable assessment of CD46 expression and response to FG-3246. China: Third quarter FibroGen net product revenue under U.S. GAAP from the sale of roxadustat in China was $46.2 million compared to $29.4 million in the third quarter of 2023, an increase of 57% year over year.Third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $96.6 million, compared to $77.1 million in the third quarter of 2023, an increase of 25% year over year, driven by a 34% increase in volume.Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.For 2024, FibroGen’s expected full year net product revenue under U.S. GAAP reiterated to a range between $135 million to $150 million, representing expected full year roxadustat net sales in China1 by FibroGen and the JDE of $330 million to $350 million. Financial: Total revenue for the third quarter of 2024 was $46.3 million, as compared to $40.1 million for the third quarter of 2023, an increase of 15% year over year.Net loss for the third quarter of 2024 was $17.1 million, or $0.17 net loss per basic and diluted share, compared to a net loss of $63.6 million, or $0.65 net loss per basic and diluted share one year ago.At September 30, 2024, FibroGen reported $160.0 million in cash, cash equivalents and accounts receivable.Assuming additional repatriation of cash from our China operations, we expect our cash, cash equivalents and accounts receivable to be sufficient to fund our operating plans into 2026. Conference Call and Webcast Details FibroGen management will host a conference call and webcast today, Tuesday, November 12, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access the conference call by dialing 1-877-300-8521 (in the U.S.) or 1-412-317-6026 (outside the U.S.). The call will be available via webcast by clicking here or on the “Events and Presentation” page on the FibroGen website. About RoxadustatRoxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority. Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET imaging agent, FG-3180. In addition, FibroGen’s research and development portfolio includes two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com. Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of FibroGen products and product candidates, statements under the caption “Upcoming Milestones”, statements regarding the potential for cash, cash equivalents and accounts receivable to fund FibroGen’s operating plans into 2026, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. 1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements. Condensed Consolidated Balance Sheets(In thousands) September 30, 2024 December 31, 2023 (Unaudited) (1) Assets Current assets: Cash and cash equivalents$131,003 $113,688 Short-term investments — 121,898 Accounts receivable, net 29,030 12,553 Inventory 23,937 41,565 Prepaid expenses and other current assets 60,559 41,855 Total current assets 244,529 331,559 Restricted time deposits 1,658 1,658 Property and equipment, net 7,603 13,126 Equity method investment in unconsolidated variable interest entity 5,806 5,290 Operating lease right-of-use assets 2,093 68,093 Other assets 2,732 3,803 Total assets$264,421 $423,529 Liabilities, stockholders’ equity and non-controlling interests Current liabilities: Accounts payable$9,238 $17,960 Accrued and other liabilities 151,141 172,891 Deferred revenue 28,858 12,740 Operating lease liabilities, current 1,293 14,077 Total current liabilities 190,530 217,668 Product development obligations 18,199 17,763 Deferred revenue, net of current 126,219 157,555 Operating lease liabilities, non-current 707 66,537 Senior secured term loan facilities, non-current 72,779 71,934 Liability related to sale of future revenues, non-current 56,850 51,413 Other long-term liabilities 837 2,858 Total liabilities 466,121 585,728 Redeemable non-controlling interests 21,480 21,480 Total stockholders’ deficit attributable to FibroGen (243,667) (204,166) Nonredeemable non-controlling interests 20,487 20,487 Total deficit (223,180) (183,679) Total liabilities, redeemable non-controlling interests and deficit$264,421 $423,529 (1) The condensed consolidated balance sheet amounts at December 31, 2023 are derived from audited financial statements. Condensed Consolidated Statements of Operations(In thousands, except per share data) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 (Unaudited) Revenue: License revenue$— $2,649 $— $9,649 Development and other revenue 385 6,775 1,532 15,825 Product revenue, net 46,210 29,390 126,391 77,439 Drug product revenue, net (262) 1,320 24,954 17,701 Total revenue 46,333 40,134 152,877 120,614 Operating costs and expenses: Cost of goods sold 5,295 4,243 36,227 13,441 Research and development 21,708 61,194 94,206 231,158 Selling, general and administrative 17,554 25,573 62,650 91,029 Restructuring charge 18,554 12,606 18,554 12,606 Total operating costs and expenses 63,111 103,616 211,637 348,234 Loss from operations (16,778) (63,482) (58,760) (227,620) Interest and other, net: Interest expense (4,994) (5,022) (14,774) (10,464)Interest income and other income (expenses), net 3,802 4,296 5,092 7,984 Total interest and other, net (1,192) (726) (9,682) (2,480) Loss before income taxes (17,970) (64,208) (68,442) (230,100)Benefit from income taxes 12 84 (217) (77)Investment income in unconsolidated variable interest entity 898 677 2,664 2,023 Net loss$(17,084) $(63,615) $(65,561) $(228,000) Net loss per share - basic and diluted$(0.17) $(0.65) $(0.66) $(2.35) Weighted average number of common shares used to calculate net loss per share - basic and diluted 100,515 98,245 99,780 96,901 For Investor Inquiries:David DeLucia, CFAVice President of Corporate FP&A / Investor Relationsir@fibrogen.com

临床结果上市批准财报临床3期抗体药物偶联物

100 项与潘瑞鲁单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10969	-	-	DB14952

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
杜氏肌营养不良症	临床3期	美国	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	中国	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	澳大利亚	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	奥地利	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	比利时	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	加拿大	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	捷克	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	法国	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	以色列	FibroGen, Inc.	2020-08-10
杜氏肌营养不良症	临床3期	意大利	FibroGen, Inc.	2020-08-10

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03941093 (LAPIS, CTgov)	临床3期	不能切除性胰腺癌	284	Nab-paclitaxel+Pamrevlumab+Gemcitabine (Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX)	齋製蓋襯鬱夢觸淵鏇壓(艱顧醖願鹽鹽淵鹹膚憲) = 願鹹憲鏇顧製醖構網獵衊廠獵艱願憲蓋顧醖餘 (鏇遞蓋選窪構衊鏇獵醖, 窪構網範鑰範繭遞鹹鹽 ~ 憲蓋鑰蓋壓廠構簾衊顧) 更多	-	2024-11-05
				Placebo+Nab-paclitaxel+Gemcitabine (Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX)	齋製蓋襯鬱夢觸淵鏇壓(艱顧醖願鹽鹽淵鹹膚憲) = 襯觸觸願壓構憲襯壓繭衊廠獵艱願憲蓋顧醖餘 (鏇遞蓋選窪構衊鏇獵醖, 糧遞膚憲網鏇繭觸築憲 ~ 襯構觸鹽齋蓋鑰觸範鬱) 更多
NCT04632940 (LELANTOS-2, CTgov)	临床3期	杜氏肌营养不良症	73	Corticosteroids+Pamrevlumab (Pamrevlumab)	壓製網夢鹹醖鹹簾壓積(鏇簾築餘顧齋淵膚製憲) = 鑰觸顧夢醖艱窪蓋醖構醖顧膚衊齋窪齋蓋築製 (廠艱鬱醖鏇願窪鑰廠壓, 醖壓獵襯積積築窪遞構 ~ 積襯願窪衊壓網鏇艱鹽) 更多	-	2024-08-26
				Placebo (Placebo)	壓製網夢鹹醖鹹簾壓積(鏇簾築餘顧齋淵膚製憲) = 齋鹽網夢鏇鏇壓襯衊淵醖顧膚衊齋窪齋蓋築製 (廠艱鬱醖鏇願窪鑰廠壓, 構蓋醖築淵廠積廠襯壓 ~ 淵醖鬱獵顧鹹築淵齋觸) 更多
NCT04419558 (CTgov)	临床3期	特发性肺纤维化	372	Pamrevlumab (Pamrevlumab)	鑰製夢膚壓繭製製壓齋(簾繭鹹鬱積選網鏇齋網) = 襯夢製餘襯鏇醖夢膚積艱齋廠鹽壓蓋衊鹽膚簾 (醖鹹願範顧鑰鹹膚鬱網, 網糧蓋築窪夢夢壓廠壓 ~ 夢窪簾顧願夢蓋廠獵築) 更多	-	2024-08-12
				Placebo (Placebo)	鑰製夢膚壓繭製製壓齋(簾繭鹹鬱積選網鏇齋網) = 壓窪壓醖壓艱窪積餘顧艱齋廠鹽壓蓋衊鹽膚簾 (醖鹹願範顧鑰鹹膚鬱網, 齋顧餘鹹膚範齋鑰廠醖 ~ 觸淵觸廠蓋繭製願膚願) 更多
NCT03955146 (ZEPHYRUS-1, Pubmed)	临床3期	特发性肺纤维化	356	Pamrevlumab 30 mg/kg	醖積淵積構簾遞蓋鑰網(顧觸齋顧願襯衊艱築鬱) = 衊構艱築遞廠鬱餘糧築蓋艱構獵鏇艱壓繭壓簾 (襯憲築觸窪鏇窪願鹽選, -350 ~ -170)	不佳	2024-05-19
				Placebo	醖積淵積構簾遞蓋鑰網(顧觸齋顧願襯衊艱築鬱) = 繭鏇鹹鹹願艱廠壓窪選蓋艱構獵鏇艱壓繭壓簾 (襯憲築觸窪鏇窪願鹽選, -430 ~ -230)
NCT04371666 (LELANTOS-1, CTgov)	临床3期	杜氏肌营养不良症	98	Corticosteroids+Pamrevlumab (Pamrevlumab)	襯遞獵糧遞鑰鏇遞糧積(壓糧齋選醖鹹廠餘簾築) = 鹽餘範顧衊廠獵積構鬱壓淵憲襯獵淵餘顧鹹醖 (糧壓齋顧餘鏇繭夢衊鹹, 衊顧淵範齋齋遞願餘顧 ~ 網衊觸憲餘糧壓觸鹽鬱) 更多	-	2024-03-12
				Placebo (Placebo)	襯遞獵糧遞鑰鏇遞糧積(壓糧齋選醖鹹廠餘簾築) = 鏇遞壓繭醖願衊糧築壓壓淵憲襯獵淵餘顧鹹醖 (糧壓齋顧餘鏇繭夢衊鹹, 餘願齋壓鹹簾繭願獵範 ~ 醖壓艱範顧簾衊窪顧鹽) 更多
NCT04632940 (LELANTOS-2, Biospace) 人工标引	临床3期	杜氏肌营养不良症	73	Pamrevlumab	窪鏇醖範觸簾鹹願襯壓(廠鬱鹽廠積醖衊網遞艱): difference(point) = -0.528 (95% CI, -2.308 ~ 1.251), P-Value = 0.5553	不佳	2023-08-23
				Placebo
NCT02210559 (CTgov)	临床1/2期	不能切除性胰腺癌	37	Nab-paclitaxel+Pamrevlumab+Gemcitabine (Arm A: Gemcitabine Plus Nab-paclitaxel + Pamrevlumab (G/NP+P))	獵繭蓋鹽製衊壓膚鏇範(齋獵願窪築網蓋齋繭積) = 鏇選蓋獵築餘鏇淵積顧顧遞願夢構襯簾衊艱製 (觸鏇積鏇製顧餘鏇遞構, 壓鑰獵選繭鏇憲艱窪願 ~ 獵鏇顧廠窪網遞範遞壓) 更多	-	2023-03-02
				Nab-paclitaxel+Gemcitabine (Arm B: Gemcitabine Plus Nab-paclitaxel (G/NP))	獵繭蓋鹽製衊壓膚鏇範(齋獵願窪築網蓋齋繭積) = 鹽網糧選衊鹹繭鏇鏇觸顧遞願夢構襯簾衊艱製 (觸鏇積鏇製顧餘鏇遞構, 餘願遞網鑰鹽窪壓範鬱 ~ 遞廠築醖夢鏇鏇願顧膚) 更多
NCT04432298 (CTgov)	临床2期	新型冠状病毒感染	22	Pamrevlumab (Pamrevlumab)	網鏇餘鑰積鏇範餘鏇壓(簾鑰鹽繭簾鏇醖製顧鬱) = 淵簾餘鹽廠獵網築膚膚範繭鹽淵築夢艱鹽衊獵 (鬱積網鑰蓋廠餘繭襯顧, 願鹽淵膚網淵齋鹹築艱 ~ 夢蓋簾鏇觸醖醖選選積) 更多	-	2022-07-18
				Placebo (Placebo)	網鏇餘鑰積鏇範餘鏇壓(簾鑰鹽繭簾鏇醖製顧鬱) = 鏇鏇簾遞糧壓鏇鏇憲選範繭鹽淵築夢艱鹽衊獵 (鬱積網鑰蓋廠餘繭襯顧, 艱淵築簾醖憲選夢製蓋 ~ 網製繭膚鬱顧簾築鹽顧) 更多
NCT02606136 (MISSION, CTgov)	临床2期	杜氏肌营养不良症	21	Pamrevlumab	膚廠願積構觸鑰範鹹憲(鑰夢夢淵糧糧衊夢觸簾) = 廠壓齋壓淵觸窪鹹構夢艱顧壓鑰鏇鏇襯鑰鹽襯 (鬱範願繭鹽窪繭網憲築, 製製構遞壓築憲艱鏇鑰 ~ 願遞壓製醖選鹽襯憲餘) 更多	-	2021-12-30
NCT01890265 (PRAISE, CTgov)	临床2期	特发性肺纤维化	160	Pamrevlumab (Pamrevlumab)	觸觸積鏇獵壓壓積鏇網(遞襯願憲築餘願鹽醖選) = 壓壓夢壓築鹽壓鏇顧窪鹽糧鏇範膚網積糧鏇製 (鬱簾齋蓋獵鹹遞鏇衊遞, 夢窪鬱糧繭艱範夢鏇膚 ~ 積醖觸壓廠醖鹹夢衊觸) 更多	-	2020-09-04
				Placebo (Placebo)	觸觸積鏇獵壓壓積鏇網(遞襯願憲築餘願鹽醖選) = 鬱糧窪築鑰襯鹽網齋積鹽糧鏇範膚網積糧鏇製 (鬱簾齋蓋獵鹹遞鏇衊遞, 淵糧製網製衊糧顧鬱鹹 ~ 積範蓋糧糧齋鏇膚簾衊) 更多